Phase 3 N=180 Randomized Treatment

Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin

Cervical Ripening · Induction of Labor · Multiparity

Bottom Line

View on ClinicalTrials.gov: NCT03138252 ↗

Enrolled (actual)

180

Serious AEs

1.1%

Results posted

May 2022

Primary outcome: Primary: Time From Cervical Ripening to Delivery — 16.88; 13.13 hours

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Oxytocin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Cervical Ripening to Delivery	16.88; 13.13	—

Summary

Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix. Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.

Eligibility Criteria

Inclusion Criteria

Age > 18 years
Gestational age > 34 + 0/7 weeks
Prior spontaneous vaginal delivery
Clinical or U/S EFW of 1 prior C/S

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03138252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.